Mesial Temporal Lobe EpilepsyNCT04710004
Electrophysiological Biomarkers in MTLE Patients.
A study testing Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device in people with Mesial Temporal Lobe Epilepsy, run by Emory University at 1 site in United States.
Trial summary
The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mesial Temporal Lobe Epilepsy
- What is being tested?
- Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2021to 16 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Male or female, aged 18-65
- Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
- Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
Who cannot join
- Any patient who is unwilling or unable to provide consent
- Women who are pregnant
- Patients under 18 years
- Incarcerated persons
Trial locations and contacts
1 site in 1 country.
United States1 site
Epilepsy monitoring unit (EMU) at Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.
The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.
Read the detailed description
This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).
- Conditions
- Mesial Temporal Lobe Epilepsy
- Being tested
- Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device
- Keywords
- Epilepsy, Biomarkers
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation deviceDevice
Also called ADMES
Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.
| Study group | Role | What they receive |
|---|---|---|
| Brain stimulation via clinically implanted electrodes | Experimental | Brain will be stimulated in different patterns including synchronized or asynchronous current. Receives: Device: Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intracranial EEG Recording: Spectral Power From Baseline
Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.
Measured: Baseline, up to 6 weeks postintervention
Change in Intracranial EEG Recording: Synchrony From Baseline
Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation [-1 to 1] between two time series.
The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.
Measured: Baseline, up to 6 weeks postintervention
Secondary outcomes (1)
Changes in Memory During Brain Stimulation From Baseline
Patients will be asked to recall a list of words after a 20-second delay in which they will do simple math problems to ensure long-term memory encoding. Three ~1-2-hour sessions will be performed; each session will consist of 24 free recall tasks (12 during ADMES and 12 with no stimulation). The memory score will be assessed as the percentage correct out of 12. The higher the percentage recalled, the better the score.
Measured: Baseline, up to 6 weeks postintervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start30 Nov 2021
- Primary completion16 Dec 2021
- Study completion16 Dec 2021
Why it stopped: Lack of funding to secure effort for testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mesial Temporal Lobe EpilepsyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Gross, Emory University
- Investigators
- Robert Gross, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710004
- Sponsor's protocol ID
- STUDY00001554
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2021
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.
- ClinicalTrials.gov ID
- NCT04710004
- Acronym / sponsor ID
- STUDY00001554
- Conditions
- Mesial Temporal Lobe Epilepsy
- Keywords
- Epilepsy, Biomarkers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to secure effort for testing.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 16 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.
Detailed description
This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain stimulation via clinically implanted electrodes | Experimental | Device: Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation deviceBrain will be stimulated in different patterns including synchronized or asynchronous current. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Male or female, aged 18-65
- Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
- Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
Key exclusion criteria (4 listed)
- Any patient who is unwilling or unable to provide consent
- Women who are pregnant
- Patients under 18 years
- Incarcerated persons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation deviceAlso: ADMESParticipants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies. | Device | Brain stimulation via clinically implanted electrodes |
Primary outcome
Change in Intracranial EEG Recording: Spectral Power From Baseline
Time frame: Baseline, up to 6 weeks postintervention
Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.
Change in Intracranial EEG Recording: Synchrony From Baseline
Time frame: Baseline, up to 6 weeks postintervention
Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation [-1 to 1] between two time series. The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.
1 secondary outcome
Changes in Memory During Brain Stimulation From Baseline
Time frame: Baseline, up to 6 weeks postintervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Mesial Temporal Lobe Epilepsy
RecruitingPhase 1
A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy
Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingEarly Phase 1
Pharmacological Modulation of Brain Oscillations in Memory Processing
Epilepsy, Seizures
RecruitingPhase 1/2
AMT-260 Gene Therapy Study in Adults With Unilateral Refractory Mesial Temporal Lobe Epilepsy
Mesial Temporal Lobe Epilepsy
Recruiting
PRIME: PReservIng Memory in Epilepsy
Mesial Temporal Lobe Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Gross, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device in people with Mesial Temporal Lobe Epilepsy, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intracranial EEG Recording: Spectral Power From Baseline (time frame: Baseline, up to 6 weeks postintervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.